Safety and Efficacy of Avapritinib in Chinese Patients With Gastrointestinal Stromal Tumor (GIST) in the Real World

CStone Pharmaceuticals

Status: Completed

Conditions: Gastrointestinal Stromal Tumors

Treatments: Drug: Avapritinib; Drug: Tyrosine kinase inhibitors other than avapritinib ( imatinib, sunitinib, et al )

Study type: Observational

Funder types: Industry

Identifiers

NCT05381753

Avapritinib-4-001

Details and patient eligibility

About

This study is an observational, multicenter, Real-word study to evaluate the safety and clinical efficacy of avapritinib in Chinese subjects with GIST.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cohort 1 and 4: Participants must have a confirmed diagnosis of unresectable GIST with mutations in the PDGFRα gene exon 18.
• Cohort 2: Participants must have a confirmed diagnosis of GIST with mutations in the PDGFRα gene exon 18 and was/will be administrated avapritinib in an neoadjuvant and/or adjuvant setting.
• Cohort 3: Participants must have a confirmed diagnosis of unresectable GIST without mutations in the PDGFRα gene exon 18, KIT gene exon 13, and KIT gene exon 14.

Exclusion criteria

• Participants who have participated and may participate in any other interventional clinical trail in the future.
• Participants with any comorbidities not suitable for avapritinib (other TKIs, Cohort 4) treatment assessed by researchers.

Trial design

61 participants in 4 patient groups

Ava-mGSIT-P18

Description:

Unresectable or metastatic PDGFRA exon 18 GIST

Treatment:

Drug: Avapritinib

Ava-Perioperative

Description:

Perioperative PDGFRA exon 18 GIST

Treatment:

Drug: Avapritinib

Ava-mGIST-other

Description:

Unresectable or metastatic GIST without KIT exon 13，14，or PDGFRA exon 18 mutation

Treatment:

Drug: Avapritinib

TKI

Description:

Unresectable or metastatic PDGFRA exon 18 GIST

Treatment:

Drug: Tyrosine kinase inhibitors other than avapritinib ( imatinib, sunitinib, et al )